Peter Calcott

A native of the UK, Dr. Calcott has a career spanning 4 decades and has worked for Pharma companies such as SmithKline Beecham, Monsanto and Bayer as well as biotechnology companies such as Immunex, Chiron and PDL. He has held positions in R&D, Manufacturing, QA & QC, Process Development, Corporate Compliance, Business Development, and Government Affairs. He has worked on biologics (vaccines, recombinant proteins, monoclonal antibodies, blood products), drugs and generics from early development to commercial. Prior to entering industry he taught at university. He is a member of the Board for BayBio and is chairman of the RAC committee of BIO. Dr. Calcott has a BS from University of East Anglia and D.Phil from University of Sussex in the UK. While in Academia he was a consultant to University, government and industry. He has published over 90 research articles, reviews and books.

Posts by Peter Calcott:

• How is Process Validation progressing now that guidances have been issued?

  01 Mar 2016 in Commercial Manufacturing & FDA Guidance & GMP & Process Validation & Quality Management Systems & Risk Management

  Guidances have been issued by the FDA and EMA for over three years now.  So are companies complying or are they finding it tough?  Read an article I wrote in Contract Pharma Article.  Happy reading

• Single use components in biopharm – a regulatory perspective

  04 Feb 2016 in Clinical Manufacturing & Commercial Manufacturing & Contract Manufacturing & FDA Guidance & GMP & Quality Agreements & Quality Management Systems

  Single use components have been used in operations for decades but their use is expanding rapidly.  The agencies are taking a closer look.  Just published an interesting article on the topic in BioPharmaceutical International . Enjoy the read

• All articles seen to focus on how to set up successful relationships with CMOs. What do you do if it begins to go south and prevent it happening again?

  14 Jan 2016 in News

  Just published an article in Medicine Maker (Medicine Maker article).  The focus is to identify when and if a relationship goes south.  It identifies the issues and how to avoid getting trapped.  Happy reading.

• Good CAPAs require good investigations – driving out human error from the work place

  04 Sep 2015 in Commercial Manufacturing & GMP & inspections & News & Quality Management Systems & regulatory citations & Warning Letter

  Do you have deviations that just won’t go away?  Do they disappear for a couple of months only to reappear a few months later stronger than ever?  Have you ever wondered why? I won’t try to say that there is one cause for this but one that I have found continuously is Human Error as […]

• Operation Excellence strikes again

  09 Jul 2015 in Commercial Manufacturing & Contract Manufacturing & GMP & Quality Management Systems & Risk Management & Warning Letter

  You’ve heard of it. You’ve probably experienced it. You may even have survived it. Yes, I am talking about “Project Operations Excellence”. Don’t get me wrong. The principles behind it are very good, even admirable. The premise is that we are operating presently as a result of processes that have evolved over time. A Band-Aid […]